Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women

NCT01219595 | Completed

• 1 other identifier: H-2010-0107
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.

Conditions

Urinary Tract Infection

Keywords

Urinary Tract Infection; UTI

Outcome Measures

Primary Outcomes (8)

• Pre-treatment heterogeneity or prevalence

  1\) Prevalence or heterogeneity of E. coli strains in UTI susceptible women pre-treatment

  Day 1 - prior to start of study treatment

• Post-treatment heterogeneity

  2\) a change in the heterogeneity of strains post treatment

  2 weeks, 1 month, or 3 months

• Patient acceptance of study regimen

  3\) patient acceptance of the study regimen

  2 weeks, 1 month, or 3 months

• Maintenance of heterogeneity in the intestinal flora

  To determine whether a shift towards strain heterogeneity in the intestinal flora can be maintained over a three month period.

  Approximately 3 months

• Measure Effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures

  Measure effects of sweetened, dried cranberries on E. coli clonotypes over three two-week exposures

  Approximately 3 months

• Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure

  Measure effects of sweetened, dried cranberries on E. coli clonotypes over one 4-week exposure

  2 weeks, 1 month, or 3 months

• Measure the UTI recurrence

  Measure the UTI recurrence after 6 months from the beginning of the study.

  2 weeks, 1 month, or 3 months

• Comparison of sweetened dried cranberries to a placebo group

  Comparison of sweetened dried cranberries to a placebo group (strawberry fruit pieces)

  2 weeks, 1 month, or 3 months

Study Arms (6)

Part 1

ACTIVE COMPARATOR

1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.

Other: Sweetened, dried cranberries

No treatment

OTHER

20 non-UTI susceptible women will be enrolled to collect data on the types of E. coli flora present in non-UTI women.

Other: Observation

Part 2A

ACTIVE COMPARATOR

1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.

Other: Sweetened, dried cranberries

Part 2B

PLACEBO COMPARATOR

1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.

Other: Strawberry Fruit Pieces

Part 3A

ACTIVE COMPARATOR

1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.

Other: Sweetened, dried cranberries

Part 3B

PLACEBO COMPARATOR

1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.

Other: Strawberry Fruit Pieces

Interventions

Sweetened, dried cranberries OTHER

Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.

Part 1; Part 2A; Part 3A

Strawberry Fruit Pieces OTHER

1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.

Part 2B; Part 3B

Observation OTHER

Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.

No treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, ages 18-65
• History of recurrent urinary tract infections defined as three in the past year, or two in the last six months
• Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.
• The non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.

You may not qualify if:

• Women who:
• Are pregnant
• Have an immune compromising disease
• Have diabetes
• Have kidney stones
• Have chronic bowel inflammatory disease
• Have known allergies to cranberries, strawberries, elderberries, or wheat fiber
• Non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Ocean Spray Cranberries, Inc.: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Walter Hopkins, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)